投资建议与投资标的 ⚫ 本次 ASCO 大会上国外创新药取得了重要突破，同时国产创新药也展现了强大竞争 力，建议关注具备国际竞争优势的创新药企业，如：三生制药、三生国健、信达生 物、科伦博泰生物-B、映恩生物-B、百利天恒、泽璟制药-U、再鼎医药、荣昌生 物、中国生物制药、和黄医药等。 风险提示 医药生物行业 行业研究 | 深度报告 ASCO 见证国产创新药闪耀全球 ——2025 ASCO 部分重点研究梳理 核心观点 创新药研发失败的风险； 市场竞争加剧的风险； 创新药商业化的风险等。 国家/地区 中国 行业 医药生物行业 报告发布日期 2025 年 06 月 05 日 看好（维持） | 伍云飞 | wuyunfei1@orientsec.com.cn | | --- | --- | | | 执业证书编号：S0860524020001 | | | 香港证监会牌照：BRX199 | | 傅肖依 | fuxiaoyi@orientsec.com.cn | | | 执业证书编号：S0860524080006 | | | | | 创新领航，春华秋实：——医药生物 2024 | 2025-05-06 | | --- | ...

医药生物行业 行业研究 | 深度报告 ASCO 见证国产创新药闪耀全球 ——2025 ASCO 部分重点研究梳理 核心观点 投资建议与投资标的 ⚫ 本次 ASCO 大会上国外创新药取得了重要突破，同时国产创新药也展现了强大竞争 力，建议关注具备国际竞争优势的创新药企业，如：三生制药、三生国健、信达生 物、科伦博泰生物-B、映恩生物-B、百利天恒、泽璟制药-U、再鼎医药、荣昌生 物、中国生物制药、和黄医药等。 风险提示 创新药研发失败的风险； 市场竞争加剧的风险； 创新药商业化的风险等。 国家/地区 中国 行业 医药生物行业 报告发布日期 2025 年 06 月 05 日 看好（维持） | 伍云飞 | wuyunfei1@orientsec.com.cn | | --- | --- | | | 执业证书编号：S0860524020001 | | | 香港证监会牌照：BRX199 | | 傅肖依 | fuxiaoyi@orientsec.com.cn | | | 执业证书编号：S0860524080006 | | | | | 创新领航，春华秋实：——医药生物 2024 | 2025-05-06 | | --- | ...

Core Insights - Amgen's Imdelltra (tarlatamab-dlle) shows promising results in treating small cell lung cancer (SCLC), demonstrating a 40% reduction in the risk of death and extending median overall survival by more than five months compared to standard chemotherapy [1][2][5] Clinical Data - The global phase III DeLLphi-304 study reported a median overall survival of 13.6 months for patients treated with Imdelltra, compared to 8.3 months for the control group [3][5] - Imdelltra also exhibited a statistically significant improvement in median progression-free survival compared to standard-of-care chemotherapy [3][5] - The drug was well-tolerated, with most adverse events being mild to moderate in severity [4][5] Market Context - SCLC accounts for approximately 15% of over 2.4 million global lung cancer cases annually, with a low five-year survival rate of 5-10% across all stages [8] - Amgen's stock has increased by 10.7% year-to-date, contrasting with a 3.9% decline in the industry [4] Regulatory Approval - Imdelltra received FDA approval in 2024 for pre-treated extensive-stage SCLC patients under the accelerated approval pathway, marking it as the first DLL3-targeting BiTE therapy [9] - The drug generated sales of $81 million in Q1 2025, reflecting a 21% sequential increase driven by volume growth [10] Future Outlook - Continued approval of Imdelltra is contingent on the success of the ongoing phase III DeLLphi-304 study, which serves as the confirmatory study for the extensive-stage SCLC indication [10]

Core Insights - Amgen's IMDELLTRA® (tarlatamab-dlle) has shown a 40% reduction in the risk of death and an increase in median overall survival by over five months compared to standard-of-care chemotherapy for small cell lung cancer patients who have progressed after platinum-based chemotherapy [1][3][5] Group 1: Clinical Trial Results - The Phase 3 DeLLphi-304 trial met its primary endpoint of overall survival (OS) and key secondary endpoint of progression-free survival (PFS) [2][5] - Median OS for IMDELLTRA was 13.6 months compared to 8.3 months for standard chemotherapy, with a hazard ratio of 0.60 [1][3] - Median PFS was also significantly improved for IMDELLTRA at 4.2 months versus 3.7 months for standard chemotherapy, with a hazard ratio of 0.71 [3][5] Group 2: Patient Outcomes - IMDELLTRA significantly improved patient-reported outcomes related to cancer symptoms such as dyspnea and cough compared to the control arm [2] - The safety profile of IMDELLTRA was consistent with known profiles, showing lower rates of grade 3 or higher treatment-related adverse events (TRAEs) at 27% compared to 62% in the control arm [4][5] Group 3: Mechanism and Indication - IMDELLTRA is a first-in-class targeted immunotherapy designed to bind to DLL3 on tumor cells and CD3 on T cells, activating T cells to kill DLL3-expressing SCLC cells [6][7] - It is indicated for adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have disease progression after platinum-based chemotherapy [7][8] Group 4: Industry Context - Small cell lung cancer (SCLC) is known for its aggressive nature, with a low five-year survival rate of 5-10% across all stages [8] - SCLC accounts for approximately 15% of the over 2.4 million lung cancer diagnoses globally each year [8]